A dose-reduction HPV vaccine immunobridging trial of two HPV vaccines among adolescent girls in Tanzania (the DoRIS trial) - Study protocol for a randomised controlled trial.
A dose-reduction HPV vaccine immunobridging trial of two HPV vaccines among adolescent girls in Tanzania (the DoRIS trial) - Study protocol for a randomised controlled trial.
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减少剂量的HPV疫苗在坦桑尼亚青春期女孩中的两种HPV疫苗免疫增强试验(Doris试验)-随机对照试验的研究方案。
DOI：
10.1016/j.cct.2021.106266
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发表时间：
2021-03
影响因子：
2.2
通讯作者：
Watson-Jones D
中科院分区：
文献类型：
--
作者：
Baisley KJ;Whitworth HS;Changalucha J;Pinto L;Dillner J;Kapiga S;de Sanjosé S;Mayaud P;Hayes RJ;Lacey CJ;Watson-Jones D
人乳头瘤病毒(HPV)感染是宫颈癌的主要原因。2018年，世界卫生组织(WHO)总干事宣布致力于消除宫颈癌，将HPV疫苗接种作为优先事项。然而，建立多剂人乳头瘤病毒疫苗接种计划的成本仍然是引入该计划的障碍。我们正在坦桑尼亚进行一项减少HPV疫苗剂量计划的随机对照试验，以确定单剂疫苗是否会产生有效预防宫颈癌的免疫反应。坦桑尼亚Mwanza的930名9-14岁女孩被随机分配到6组中的一组，包括3种不同剂量的2价(Cervarx)和9价(Gardasil-9)HPV疫苗：3剂；2剂，间隔6个月；或单剂。所有参与者将被跟踪36个月；1和2剂组的参与者将被跟踪60个月。试验结果侧重于疫苗免疫反应，包括HPV16/18特异性抗体水平、抗体亲和力和记忆B细胞反应。结果将对已证明有效的女孩和年轻妇女的历史队列进行免疫接种。这是第一次在目标年龄组进行单剂HPV疫苗计划的随机试验。这项试验将使我们能够检查在疟疾和其他可能影响疫苗免疫反应的感染负担较高的人群中，减少剂量计划的免疫反应的质量和持久性。初步结果(24个月)预计将于2021年初公布。
Human papillomavirus (HPV) infection is the primary cause of cervical cancer. In 2018, the World Health Organization (WHO) Director General announced his commitment to eliminate cervical cancer, with HPV vaccination as a priority. However, the costs of setting up a multi-dose HPV vaccination programme remain a barrier to its introduction. We are conducting a randomised-controlled trial of reduced dose schedules of HPV vaccine in Tanzania to establish whether a single dose produces immune responses that will be effective in preventing cervical cancer. 930 girls aged 9–14 years in Mwanza, Tanzania, were randomised to one of 6 arms, comprising 3 different dose schedules of the 2-valent (Cervarix) and 9-valent (Gardasil-9) HPV vaccines: 3 doses; 2 doses given 6 months apart; or a single dose. All participants will be followed for 36 months; those in the 1 and 2 dose arms will be followed for 60 months. Trial outcomes focus on vaccine immune responses including HPV 16/18-specific antibody levels, antibody avidity, and memory B cell responses. Results will be immunobridged to historical cohorts of girls and young women in whom efficacy has been demonstrated. This is the first randomised trial of the single dose HPV vaccine schedule in the target age group. The trial will allow us to examine the quality and durability of immune responses of reduced dose schedules in a population with high burden of malaria and other infections that may affect vaccine immune responses. Initial results (24 months) are expected to be published in early 2021.
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DOI：
10.4161/hv.7.12.18322
发表时间：
2011-12-01
期刊：
HUMAN VACCINES
影响因子：
--
作者：
Romanowski, Barbara;Schwarz, Tino F.;Descamps, Dominique
通讯作者：
Descamps, Dominique
影响因子：
11.1
作者：
Levin, Carol E.;Hoang Van Minh;LaMontagne, D. Scott
通讯作者：
LaMontagne, D. Scott
影响因子：
5.5
作者：
Brown, Joelle;Baisley, Kathy;Watson-Jones, Deborah
通讯作者：
Watson-Jones, Deborah
DOI：
10.4161/hv.7.12.18281
发表时间：
2011-12-01
期刊：
HUMAN VACCINES
影响因子：
--
作者：
Einstein, Mark H.;Baron, Mira;Dubin, Gary
通讯作者：
Dubin, Gary
影响因子：
2.2
作者：
Liu M;Li Q;Lin J;Lin Y;Hoffman E
通讯作者：
Hoffman E